Gastroparesis, Scleroderma, Systemic Sclerosis (SSc)
Conditions
Keywords
TENS, Scleroderma, Gastroparesis, Pilot Study, Systemic Sclerosis
Brief summary
The goal of this pilot study is to assess the acceptability of the transcutaneous electrical acustimulation (TEA) device in treating Scleroderma-related gastroparesis. The main objective is: To evaluate the acceptability of TEA as an intervention for alleviating symptoms of distension and bloating in individuals diagnosed with Scleroderma. Participants will be provided with the TEA devices that will be applied to the skin for a total of 45 minutes twice daily after meals. Participants will be asked to fill out both daily diaries and biweekly questionnaires to assess for improvement in the gastroparesis symptoms. Participants will also be asked to complete the daily diaries in addition weekly questionnaires during a 4 week post-treatment follow-up period.
Interventions
DEVICETranscutaneous Electrical Nerve Stimulation
Patients will utilize the TENS device for 45 minutes, two times per day for the 4 week treatment period.
Sponsors
University of Michigan
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Classification of Systemic Sclerosis according to the 2013 American College of Rheumatology and European League against Rheumatism classification criteria. 2. Age \>= 18 years 3. English speaking. 4. Participants who report moderate to severe symptoms of distension/bloating on UCLA Scleroderma Clinical Trials Consortium Gastrointestinal Tract Instrument 2.0 5. Stable GI specific therapy including prokinetics over the last 4 weeks.
Exclusion criteria
1. Pregnancy, or currently lactating. 2. A history of major abdominal surgery (other than cholecystectomy, appendectomy, or deemed as non-major by the investigators) 3. Unrelated active disorder which may involve abdominal pain, such as inflammatory bowel disease, diabetes or unstable thyroid disease. 4. Known allergy to adhesive ECG electrodes. 5. Known contraindications to TEA (e.g., cardiac pacemaker, epilepsy)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Acceptability of the TENS Device | 4 weeks | Acceptability of the TENS device as demonstrated by: 1. Subjects who are able to complete the trial by reaching the end of the testing period with the device 2. Subjects who utilize the device for at least 80% of the proposed applications. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy of TENS in Treating Scleroderma-related Gastroparesis | 4 weeks | Mean change in the GCSI Total score (0-4 where higher score reflects greater severity)from baseline to after the TENS intervention. |
| Assessment of the Effect of TENS of Gastroparesis Symptoms | 4 weeks | Mean change in the ULCA-GIT 2.0 Distention/Bloating scale (0-3.0 where 0 is lowest severity and 3.0 is greatest severity) from baseline to after the TENS intervention. |
| Assessment of the Safety of TENS in Treating Scleroderma-related Gastroparesis | 8 weeks | Number of participants with treatment-related adverse events as assessed by CTCAE v5.0. The CTCAE v5.0 is a standardize tool to grade adverse events on a scale of 1 to 5, where 1 is "mild" grade 2 is "moderate", 3 is "severe", 4 is "life threatening", and 5 is "death". Outcome is shown as number of participants who experienced an adverse event in each possible grade. |
| Gastric Motility in Participants | 4 weeks | Participants were categorized as having "normal" or "abnormal" gastric motility at baseline. Those who were categorized as "abnormal" at baseline repeated the test at 4 weeks, after the intervention. Those who were classified as "normal" did not repeat the test. |
Countries
United States
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 50.8 years STANDARD_DEVIATION 9.6 |
| Baseline Gastric Motility Status Delayed liquid and solid phases | 3 Participants |
| Baseline Gastric Motility Status Delayed liquid phase only | 2 Participants |
| Baseline Gastric Motility Status Delayed solid phase only | 3 Participants |
| Baseline Gastric Motility Status Normal | 3 Participants |
| Body Mass Index (BMI) | 28.1 kg/m^2 STANDARD_DEVIATION 6.1 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 11 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Gastroparesis Cardinal Symptom Index-Daily Diary (GCSI-DD) Scores GCSI-DD Bloating | 1.4 units on a scale STANDARD_DEVIATION 0.7 |
| Gastroparesis Cardinal Symptom Index-Daily Diary (GCSI-DD) Scores GCSI-DD Total | 1.1 units on a scale STANDARD_DEVIATION 0.7 |
| Height (cm) | 163.3 cm STANDARD_DEVIATION 4.3 |
| Marital Status Married | 5 Participants |
| Marital Status Single | 4 Participants |
| Marital Status Unknown | 2 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants |
| Race (NIH/OMB) More than one race | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) White | 8 Participants |
| Sex: Female, Male Female | 11 Participants |
| Sex: Female, Male Male | 0 Participants |
| UCLA-Gastrointestinal Tract (GIT) 2.0 Scores Distension Score | 1.5 units on a scale STANDARD_DEVIATION 0.6 |
| UCLA-Gastrointestinal Tract (GIT) 2.0 Scores ULCA GIT Total Score | 0.8 units on a scale STANDARD_DEVIATION 0.4 |
| Weight (kg) | 74.8 kg STANDARD_DEVIATION 16.3 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 11 |
| other Total, other adverse events | 0 / 11 |
| serious Total, serious adverse events | 0 / 11 |
Outcome results
None listed